YLE: Finnish Customs Suspect Hundreds in Illegal Importation of Pharmaceuticals

The Finnish Broadcasting Company YLE is reporting that Finnish Customs is investigating a widespread case of illegal importation of pharmaceuticals, and hundreds of Finns are suspected of having committed a crime.

According to the report:

· Finnish Customs is focusing on more than 800 online orders of medication from abroad that were placed over a two-month period. Finnish Customs have confiscated more than 140,000 individual tablets.

· Customs officials have stated that some of the bought so-called pharmaceuticals have even been toxic.

· Certain ordered remedies were discovered to contain floor wax, for example. As far as is known, the bogus drugs have not yet caused danger to anyone’s life.

· "Anyone who orders pharmaceuticals on the Net may be guilty of a medications law violation. If the medication contains intoxicants, this may be a drug violation or a violation involving performance enhancers", the Western Customs District's anti-crime chief Hannu Sinkkonen told YLE News.

· According to Finnish Customs, organized international criminal gangs are behind the illegal drug business.

Secure Pharma Chain Blog supports the enhanced enforcement and interdiction of fraudulent, adulterated and counterfeit medications.

It has long been known and reported that unlicensed international internet sites are notorious for their high percentage of bogus medications that can cause severe health issues or death to the consumer.

It is also well known that internet sites are a significant contributor of nefarious and fake medications ending up in the legitimate pharmaceutical supply chains.

The most effective interdiction is material authentication of products within the supply chain.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

To read more about the YLE report, visit: http://www.hs.fi/english/article/YLE+Customs+suspect+hundreds+of+Finns+of+illegal+importation+of+pharmaceuticals+over+the+Internet/1135256918425.

FDA Issues Warning Letter to Perrigo Over Metal Shavings in Ibuprofen Tablets

The Detroit Free Press on May 28th reported about the FDA Warning letter sent to Perrigo Company, a generic drug developer and the largest US maker of store-brand, over-the-counter drugs.

The article written by Lori Higgins highlights the four significant violations cited by the FDA during inspections from November 17-January 14:

· Perrigo did not reject a lot of ibuprofen tablets that were contaminated by metal shavings due to an equipment failure. The FDA said that although Perrigo segregated a portion of the affected lot, it still shipped some of the lot. That resulted in a recall of the entire lot.

· Perrigo didn’t thoroughly investigate possible foreign tablet contamination in its filling equipment when it found a brown, round ibuprofen tablet from one lot included in a lot of brown, oval ibuprofen caplets. The FDA said the company should have investigated a lot of orange, round ibuprofen tablets that were packaged between the packaging of the brown, round tablets and the brown, oval caplets to ensure there was no further contamination.

· Perrigo’s quality control unit failed to follow standard operating procedures, twice resulting in the release of mislabeled products that had to be recalled.

· Perrigo failed to adequately inspect packaging and labeling facilities before use to ensure drug products had been removed from previous operations.

Additionally Ms. Higgins quotes Joann M. Givens, District Director of the Detroit FDA office in the letter. "Your firm has had an ongoing program since 2005 to address mixups. ... However, your firm continues to receive complaints regarding this issue, and despite past assurances that previous enhancements would control this problem, deviations continue."

To read the entire Detroit Free Press article, visit:
http://www.freep.com/article/20100527/BUSINESS06/100527055.

Secure Pharma Chain Blog, encourages all within the pharmaceutical supply chain to authenticate and verify their inventories from manufacturer to dispenser in order to protect the consumer from poor quality, adulteration, fraud and counterfeiting.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

New York Times: GAO Study Reveals Contaminants In Herbal Supplements

According to a New York Times article, published on May 26th, the General Accounting Office published a study that finds contaminants, some in high amounts, in all herbal dietary supplements tested by investigators.

The following are some highlights from the New York Times article:

· "Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found."

· Although the "levels of heavy metals -- including mercury, cadmium and arsenic -- did not exceed thresholds considered dangerous," almost half of them "contained pesticide residues that appeared to exceed legal limits." Notably, "Dr. Joshua M. Sharfstein, principal deputy commissioner of the Food and Drug Administration, said in an interview that he was not concerned about the safety of the supplements tested by the GAO investigators."

· Sharfstein added that "the FDA had increased enforcement actions against supplements spiked with prescription drugs."

To read the New York Times article, visit: http://www.nytimes.com/2010/05/26/health/policy/26herbal.html.

Secure Pharma Chain Blog, endorses that all members of the pharmaceutical and herbal supplement supply chain utilize authentication technologies to verify the authenticity and quality of their inventories and protect the consumer from fraudulent, adulterated and counterfeit materials.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

Johnson & Johnson Faces Possible Criminal Charges

Widely reported by most media outlets, pharmaceutical giant Johnson & Johnson and its McNeil Consumer Products division may face a variety of charges including criminal for what was described by FDA officials in a May 27th Congressional hearing as “a pattern of violations in manufacturing and quality control practices (which) led to a number of recent recalls.

The following are some of the media highlights from yesterday and today:

• ABC World News George Stephanopoulos reported, "Government officials said today they are considering criminal charges against Johnson & Johnson, stemming from last month's huge recall of Tylenol and other popular over the counter children's medicines."

• NBC Nightly News Brian Williams reported, "Johnson & Johnson insists it has taken dramatic steps to clean up the plants where the recalled products are made. Meanwhile, the FDA says it has referred the matter to its criminal division for consideration."

• The New York Times reports, "The Johnson & Johnson unit that recalled millions of bottles of liquid children's Tylenol and other pediatric medicines last month may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday." Notably, the "agency is considering further actions against McNeil Consumer Healthcare...after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls," Sharfstein "said at a Congressional hearing on Thursday."

• The Washington Post states, "When faced last year with Motrin IB caplets that were not dissolving properly, McNeil Consumer Healthcare, a division of Johnson and Johnson, hired contractors to buy the products under orders not to mention the term 'recall,' according to documents released by the House Committee on Oversight and Government Reform." Then, "after the Food and Drug Administration discovered the effort -- because one of the contractors accidentally dropped an instruction sheet on the floor of a store -- McNeil announced a recall of roughly 88,000 packages of the product." And, in the last year, there have been "four recalls of McNeil products...including the April 30 recall of 136 million bottles of infant and children's Tylenol, Motrin, Benadryl and Zyrtec, which have shaken consumers' confidence and threaten to stain Johnson and Johnson's brand name."

• The Los Angeles Times reports that following the revelations at the hearing, "Colleen Goggins, chairwoman of Johnson & Johnson's consumer division, apologized 'to the mothers and fathers and caregivers for the concern and inconvenience' caused by the April recall."

Securing Pharma Chain Blog, supports the inclusion of authentication and verification of pharmaceuticals at all members of the pharmaceutical supply chain to protect against poor manufacturing practices, fraud, adulteration and counterfeiting and avoid consumption of bogus materials by consumers.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

To read the major media stories, visit:

http://www.nytimes.com/2010/05/28/business/28drug.html?src=busln.

http://www.washingtonpost.com/wp-dyn/content/article/2010/05/27/AR2010052705484.html?hpid=moreheadlines.

http://www.latimes.com/news/nationworld/nation/la-na-tylenol-hearing-20100528,0,1137250.story.

FreightWatch International Issues Pharmaceutical Cargo Theft Alert

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released a pharmaceutical cargo theft alert.

Two trailers loaded with an undisclosed value of pharmaceuticals were taken from a trucking company parking lot in Memphis, Tennessee between 10 p.m. Thursday, May 20th and 8 a.m. Friday, May 21st.

Both trailers had been loaded at a local pharmaceutical distribution center, moved to the trucking company lot and dropped unattached to a tractor.

One of the trailers was returned to the transportation provider's lot after being taken and the pharmaceuticals removed.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To read the entire alert from Freightwatch International, visit: http://www.freightwatchintl.com/.To learn more about supply chain security solutions, visit: http://www.xstreamsystems.net/.

Bloomberg News: FDA Says Perrigo Failed To Protect Consumers From Tablets Containing Metal Shavings

In a recent Bloomberg News article, according to US regulators Perrigo failed to protect consumers from ibuprofen tablets contaminated with metal shavings, four years after the company recalled similarly tainted acetaminophen pills.

Perrigo was forced to pull the ibuprofen from the market after the tablets were released by its Allegan, Michigan, plant, according to an April 29 warning letter sent outby the Food and Drug Administration" on Tuesday.

According to the FDA, Perrigo "failed to thoroughly investigate why some tablets were the wrong size and didn't inspect packaging equipment between batches."

The warning follows Perrigo’s 2006 recall of 11 million bottles of acetaminophen pills containing pieces of wire as long as 8 millimeters (0.32 inches). The FDA ordered the company to fix its quality-control issues or face product seizure, injunction or a ban on exports or new product approvals.

Perrigo is the world’s largest maker of non-prescription, store branded drugs.

To read the Bloomberg News report, visit: http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aEYk_t22lj18.

Secure Pharma Chain blog, endorses that all members of the pharmaceutical supply chain utilize authentication technologies to verify the authenticity and quality of their inventories and protect the consumer from fraudulent, adulterated and counterfeit materials.

To learn more about supply chain authentication solutions, visit: http://www.xstreamsystems.net/.

FreightWatch International: April 2010 Cargo Theft Report

FreightWatch International, an industry leader in providing cargo theft intelligence through data collection, analysis, and customized reporting, released their monthly report on cargo theft for April 2010.

FreightWatch recorded 61 theft incidents in North America during April 2010. Of the recorded thefts in April, the highest frequency was seen in California, which contributed more than one-third of the total with 23 recorded.

By commodity, pharmaceuticals experienced three incidents in April, two less than in March.

The three pharmaceutical thefts in the report include:

• April 9th a high jacking at a public access lot in Nashville, Tennessee of undisclosed pharmaceuticals of an undisclosed value.

• April 15th warehouse burglary at a drug distribution warehouse in Richmond, British Columbia of undisclosed pharmaceuticals worth $40,000.

• April 17th theft of a trailer at a truck stop in Mill Hall, Pennsylvania of undisclosed pharmaceuticals of an undisclosed value.

The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To read the entire report from Freightwatch International, visit: http://www.freightwatchintl.com/.

To learn more about supply chain security solutions, visit: http://www.xstreamsystems.net/.

WSJ: J&J Details Recall Troubles

In the May 18 edition of the Wall Street Journal, Jonathon Rockoff writes about new details emerging from the problems with Johnson and Johnson’s production and recall of certain children's medicines. These details are coming forward as the company faces growing scrutiny in Washington, D.C.

Many of the details were obtained via a letter, dated May 1st from Johnson and Johnson to doctors and poison control officials.

Here are some of the highlights from the article:

· Some samples of recalled infants' Tylenol were tested to contain as much as 24% more active ingredient than shown on the label, according to a letter that J&J's McNeil Consumer Healthcare unit sent to doctors and poison-control officials that was reviewed by The Wall Street Journal.

· The company said the suspect medicines hadn't reached the marketplace, and its testing of other batches that had been released to the market didn't find any problems. "But we cannot confirm that all the individual bottles were within specification or that 24% would have been the maximum," according to the letter, which didn't indicate when or how the testing was done.

· The letter was dated May 1, the day after J&J recalled certain children's and infant's Benadryl, Motrin, Tylenol and Zyrtec cold and pain medicines after discovering unspecified manufacturing problems. The company said at the time that the medicines could contain higher concentrations of medicine than they should, among other potential issues, but didn't specify an amount.

· The J&J unit inadvertently neglected to include one version of Children's Zyrtec in the recall for five days, according to an email sent to the company's over-the-counter sales force. It told its sales force on May 5 that the 1 milligram grape version of children's Zyrtec "was inadvertently not included" in the recall.

· A spokeswoman for J&J's McNeil unit said the company sent the letter about infant Tylenol to health-care professionals in connection with the recall, and its "health assessment" indicates the chance that the recalled medicines will cause harm is remote.

· In conjunction with the April 30 recall, J&J's McNeil unit shut down the Fort Washington, Penn., plant that made the recalled products until it could fix the manufacturing issues and assure quality production. The company said that in addition to overly high concentrations of ingredients, the recalled liquid products may contain inappropriate levels of inactive ingredients or tiny metallic particles left as a residue from the manufacturing process.

· A Food and Drug Administration inspection of the plant had also found bacteria in raw materials set aside for use to make several lots of Tylenol.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To read the entire Wall Street Journal article, visit: http://online.wsj.com/article/SB10001424052748704912004575252923733201114.html

To learn more about supply chain security and verification solutions, visit: http://www.xstreamsystems.net/.

CNNMoney.com: Serious Side Effects of Tylenol Recall Investigated

CNNMoney.com Senior Writer Parija Kavilanz reported on May 25th on the Food and Drug Administration investigation into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson.

McNeil is also under a Congressional investigation regarding the recall, the House Committee on Oversight and Government Reform has scheduled a hearing on May 27th to examine the recall.

Highlights from the report include:

• Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.

• The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

• Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

• The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a "remote" potential for serious health problems.

• McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

McNeil's latest recall is its fourth in the past seven months:

• In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
• In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
• In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

To view the CNNMoney.com story, visit: http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm.

India's Fake Drugs Are a Real Problem

India’s Food and Drug Administration recently conducted a series of raids to combat counterfeit drugs. Large amounts of counterfeits were seized in these raids and several individuals were arrested.

Roger Bate, a leading authority on counterfeit drugs recently wrote an article for the Wall Street Journal on these raids and the prevalence of counterfeit drugs in this region.

Below are some of the highlighted statistics cited in the article:

• In 2009, Bate examined five essential medicines in 52 different pharmacies in Delhi and Chennai. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient.


• In a more recent investigation of Delhi’s wholesalers, they discovered that 7% of all tested samples were substandard and 3.6% were likely counterfeit.


• Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities.


• In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.


• Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.


• The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be.


• Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady.

In the article, Bate discusses the huge profits to be made and the necessity for stricter enforcement and how new technology can be used to combat this deadly menace.

XStream Systems has an anti-counterfeiting solution that allows wholesalers to molecularly verify the quality and authenticity of their inventory. In a world where what you see is not always what you get, our penetrating technology authenticates the medication and not just its packaging.

To learn more about XSteam Systems Solution visit: www.xstreamsystems.net.

For the full article visit: www.wsj.com.

Canadian Man Pleads Guilty to Selling Counterfeit Cancer Drugs

Tuesday, Hazim Gaber, 22 of Edmonton, Canada, pleaded guilty to selling counterfeit cancer drugs over the internet. Gaber admitted selling what he falsely claimed was the experimental cancer drug sodium dichloroacetate, also known as DCA, to at least 65 victims in the United States, Canada, the United Kingdom, Belgium and the Netherlands between October and November 2007. According to the plea agreement, Gaber charged $23.68 for 10 grams of the purported DCA, $45.52 for 20 grams or $110.27 for 100 grams, plus shipping.

DCA is an experimental cancer drug not yet approved for use in the United States or Canada. DCA is an odorless, colorless, inexpensive, relatively non-toxic experimental cancer drug that is highly sought after by cancer patients. A doctor at the University of Alberta in Canada published a report in early 2007 summarizing the results of a study, which showed that DCA caused regression in several cancers, including lung cancer, breast cancer, and cancerous brain tumors.

Gaber sold the counterfeits through a website named DCAdvice.com, which falsely claimed that it was the only authorized representative to sell DCA and was affiliated with the University of Alberta. Further lab analysis determined that the substances sold contained starch, dextrin, dextrose or lactose, and contained no DCA.

Gaber faces a maximum prison sentence of 20 years on each of the five counts of wire fraud to which he pleaded guilty. Gaber also faces maximum fines of $250,000 per count. As part of the plea agreement, Gaber agreed to forfeit or cancel any website, domain name or Internet services account related to this fraud scheme.


XStream System applauds all the regulatory and enforcement agencies involved in the capture of this counterfeiter: Criminal Division’s Computer Crime, Intellectual Property Section, Assistant U.S. Attorney Peter Sexton of the U.S. Attorney’s Office for the District of Arizona. the Edmonton Police Service, the Alberta Justice Office of Special Prosecutions-Edmonton, the Competition Bureau of Canada, the U.S. Postal Inspection Service, the Federal Trade Commission and the Alberta Partnership Against Cross Border Fraud, The Criminal Division’s Office of International Affairs and the Phoenix FBI Cyber Squad.

To view the Dept of Justice Press Release visit: www.justice.gov.

To view information regarding counterfeit detection solutions visit: www.xstreamsystems.net.

USTR Lists the Global Hotspots for Counterfeit Drugs

The United States Trade Representative (USTR) recently released their annual Special 301 report on global advances and watch lists for Intellectual Property (IP) enforcement.

The Czech Republic, Hungary, and Poland were removed from the watch list. Czech Republic was removed due to their improved board control and enactment of stricter criminal penalties. Hungary was removed due to their increase of IP enforcement. Poland was eliminated due to significant reduction of pirated goods at border markets.

Saudi Arabia was removed from watch list in Feb. 2010 for its advances in controlling the distribution of counterfeit medicines. Israel is listed as status pending as it works with USTR to resolve their problems with counterfeit medicines.

Currently countries on priority watch list include: Algeria, Argentina, Canada, Chile, China, India, Indonesia, Pakistan, Russia, Thailand, and Venezuela.

• China – although China has made great strides in IP regulation, counterfeiting still remains widespread and China’s IPR enforcement regime remains largely ineffective and non-deterrent. In China, many bulk Active Pharmaceutical Ingredients (API) used in manufacturing medicines avoid regulatory oversight by declaring falsely that they will not be used in manufacturing pharmaceutical products.


• Russia – brand manufacturers continue to report counterfeit problems of their trademarks especially for consumer goods, distilled spirits, agriculture chemicals, biotechnology, and pharmaceuticals.


• Algeria laws ban imported pharmaceuticals in favor of local production. In addition the USTR has concerns of weak protection of patents.


• Argentina has a backlog of pharmaceutical patent applications and USTR cites the need for stronger protection against IPR infringement.


• Canada - displays weak enforcement of IP rights and border protection.


• Chile - has displayed a willingness to work with the U.S. Pharma industry, but still falls short in some areas.


• India – although India has made advances in IP enforcement, the USTR still shares concerns regarding widespread counterfeit medicine and an enforcement regime that remains ineffective at addressing this problem.


• Indonesia shows an overall deterioration of IP protection and enforcement including its inability to address the counterfeiting of pharmaceutical products.


• Pakistan – has made significant advances in patent applications, but needs an effective system to address patent issues.


• Thailand – piracy and counterfeit remain widespread. In the pharmaceutical industry they need to strengthen their IP protection and enforcement.


• Venezuela - does not recognize pharmaceutical patents.

To read the entire report visit: www.ustr.gov.

McNeil Announces Sweeping Recall of Infants’ and Children's OTC Products

In an April 30th announcement, McNeil Consumer Healthcare in consultation with the U.S. Food and Drug Administration (FDA), stated that they are voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

McNeil Consumer Healthcare stated that they were initiating this voluntary recall because some of these products may not meet required quality standards.

According to McNeil the recall is not being undertaken on the basis of adverse medical events but as a precautionary measure and advises parents and caregivers should not administer these products to their children.

Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.

While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Secure Pharma Chain Blog, recommends that all members of the supply chain protect their inventories and their brand by deploying authentication and material verification that will interdict issues with adulteration, fraud, counterfeit and improper manufacturing that threaten the efficacy of pharmaceuticals and the health of consumers downstream.

In the past several years, manufacturing and quality assurance concerns by pharmaceutical companies have been discovered within the supply chain that could and should have been detected at various points of the supply chain by readily available material authentication solutions.

For a complete list of the products, visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.

To learn more about supply chain material authentication solutions, visit: http://www.xstreamsystems.net/.

FDA Sends Warning Letter to Pharmaceutical Supply Chain

In an open letter to pharmaceutical stakeholders within the supply chain, the FDA took the unusual step of warning and urging them to take further steps to protect themselves and the supply chain given the increase in cargo and warehouse thefts of FDA regulated products.

The letter signed by Michael Chappell, Acting Assistant Administrator of Regulatory Affairs appears in its entirety below:

April 28, 2010

Food and Drug Administration
Rockville, MD 20857

Dear Stakeholder:

FDA is very concerned about the increase in cargo and warehouse thefts of FDA regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula. These crimes threaten the public health because product that has left the legitimate supply chain poses potential safety risks to consumers. There have been several cases where patients experienced adverse reactions from stolen drugs, reactions that were most likely due to improper storage and handling. We do not want to see this increase in thefts continue. We would like to share our thoughts on steps that your members should take to minimize the risk of such thefts, as well as how FDA can work together with your members when a theft has occurred to address the public health risks associated with the stolen products.

Of course, the best intervention is to prevent these thefts from occurring in the first place. Firms engaged in providing medical products and infant formula to the public have a fundamental responsibility to continuously review their warehouse physicalsecurity and security practices and procedures for transporting products to ensure that measures are in place to minimize the risk of warehouse and cargo theft. These measures are important throughout the supply chain-starting from the point of manufacturing, continuing through the distribution of the product and to the retail outlet or other point where the product will be sold.

Your members should ensure that their business partners and carriers review and have strengthened their storage and in-transit security practices as welL. Your members need to be one-step ahead of thieves in securing their warehouses and product transport.

When a theft occurs, FDA is committed to work with the affected firm to minimize the public health risks and ensure an appropriate public health response. The agency has developed streamlined procedures to rapidly respond to reports of theft and ensure consistency as we work with firms that have experienced a cargo or warehouse theft.

We would like your members to promptly notify FDA's Office of Criminal Investigations (OCI) as soon as possible when a theft has occurred by contacting OCI's Headquarters office at 800-551-3989 or by accessing the OCI web site (ww.fda.gov/oci). OCI wil ask for information about the theft to assist FDA in evaluating an appropriate regulatory response. In the attached Appendix A to this letter, we have listed the types of, questions that an FDA District Office may ask about the incident. FDA also encourages prompt reporting to law enforcement agencies.

Typically, FDA's District Office closest to a firm's corporate headquarters will follow up with their regulatory contact. The District Office will request that the firm provide information pertaining to the stolen products, including a risk assessment and an actionplan, as expeditiously as possible. (See Appendix A.)

In some cases, the appropriate public health response may be a market withdrawal for product already in the supply chain with the same lot numbers as the stolen product.

We recognize the impact that such a withdrawal may have on consumers, the supply chain, and a firm's business operations, and the agency is ready to work closely with firms to determine the appropriate steps to consider in order to protect the public.Depending on the circumstances, a prompt and effective response to a theft wil reduce the need for such a market withdrawal.

Prompt public notification of the theft is a critical step in protecting the public health because it alerts others in the supply chain and the public to look out for the stolen products and to be skeptical of offers for these products at unusually low prices or from aperson outside the legitimate distribution chain. In addition, if persons in the supply chain are looking out for these products, it becomes more difficult for the thieves to sell the products back into the legitimate supply chain. If a firm experiences a cargo orwarehouse theft, we strongly encourage it to prepare a public notice for posting on its website or as a press release as soon as possible after the theft. FDA is ready to provide comment on the public notice in an expeditious manner if the firm would like toshare it with the agency before release. FDA's District Office will coordinate this review with the firm. FDA will typically provide a link to the firm's public notification on FDA's new Cargo Theft website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm182888.htm

As you may know, FDA has been working with manufacturers, wholesalers, and retailers on ways to further secure our nation's supply chain from counterfeit, diverted, unapproved, and otherwise misbranded or adulterated products. We have now addedstolen products to this effort. FDA is working with the medical products and infant formula supply chain to identify best practices and provide other guidance on how to prevent and respond to cargo/warehouse thefts.

FDA hopes and expects that your members and others in the supply chain will immediately review their in-transit and warehouse security practices and take proactive measures to prevent opportunities for theft. It is also prudent for your members to planin advance, for how they would respond to such an incident, since swift action is essential.

We look forward to continued dialogue with participants in the supply chain to identify best practices and other steps that can be taken to further ensure that American consumers can be confident about the safety and quality of medical products and infantformula sold in the U.S.

If you have any questions related to this letter or cargo theft generally, please contact Dr. Ilisa Bernstein, Director of Pharmacy Affairs, FDA, Office of the Commissioner, Office of Policy at 301-796-4723 or ilisa.bernstein@fda.hhs.gov.

Michael Chappell
Acting Assistant Adminstrator Regulatory Affairs


The issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.

As the value and prevalence increases, so too does the potential risk to consumers.

To learn more about material screening/anti-counterfeiting solutions, visit: http://www.xstreamsystems.net/.

To read the entire FDA letter online, visit: http://www.fda.gov/ICECI/CriminalInvestigations/ucm209979.htm
To learn more about material authentication solutions, visit: http://www.xstreamsystems.net/.